(63 days)
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft, when affixed to the lumbosacral spine, and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacraViliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
The purpose of the premarket notification is to add a pediatric PRC (Plate-Rod Combination) and downsized hooks to the components intended for use with AcroMed's ISOLA Spine System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.
The provided text describes a 510(k) premarket notification for the "PEDIATRIC PRC for use with the ISOLA Spine System." This document is not a clinical study report but rather a regulatory submission for device clearance. Therefore, it does not contain the typical structure of a study that establishes acceptance criteria and then proves the device meets them through clinical data.
Instead, the performance data section states: "Static and fatigue testing were conducted to characterize the performance of the devices." This implies mechanical or laboratory testing, which is common for implantable devices to ensure their structural integrity and durability. The acceptance criteria for such tests would be internal to the manufacturer's design specifications for strength, fatigue life, and other mechanical properties, and would be compared against validated methods or industry standards for similar devices.
The document then focuses on establishing "Substantial Equivalence" to previously cleared devices (K920392, K952236, and K962984) based on material, design, and intended use. This is a regulatory pathway for devices that are similar in technology and indications to existing legally marketed devices, rather than a demonstration of clinical efficacy and safety through new clinical studies.
Therefore, many of the requested points cannot be answered from the provided text, as it doesn't describe a clinical study with human subjects, ground truth establishment, or expert adjudication.
Here's a breakdown of what can be inferred or directly stated from the text regarding acceptance criteria and performance, with explanations for what cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Internal standards for static strength and fatigue life, comparable to predicate devices. | "Static and fatigue testing were conducted to characterize the performance of the devices." |
| Material Compatibility | Use of ASTM F-138 or F-1314 stainless steel, or ASTM F-136 titanium alloy. | Device is manufactured from ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy. |
| Design Equivalence | Similar design and function to predicate ISOLA PRCs and Pediatric ISOLA components. | The Pediatric PRCs and downsized hooks are substantially equivalent to the ISOLA PRCs (K920392), titanium alloy ISOLA components (K952236), and Pediatric ISOLA components (K962984). |
| Indications for Use (with pedicle screws) | Intended for grade 3 or 4 spondylolisthesis at L5-S1, utilizing autologous bone graft, fixed to lumbosacral spine, removed after solid fusion. | The device meets these indications as specified in the 510(k) clearance letter. |
Explanation: The document does not provide specific numerical acceptance limits for static and fatigue testing. It simply states that testing was conducted to "characterize" performance and that the device is "substantially equivalent" to predicate devices, implying that its performance is acceptable within the context of those predicates.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable for a clinical test set from this document. The "tests" mentioned are mechanical static and fatigue tests. The sample size for these mechanical tests is not specified.
- Data Provenance: Not applicable for a clinical test set. The mechanical testing was likely conducted by the manufacturer (AcroMed Corporation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a clinical study requiring ground truth established by medical experts. The "ground truth" for mechanical testing would be engineering specifications and industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a clinical study involving human readers or interpretation of medical data. Adjudication methods are relevant for subjective assessments, which are not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a 510(k) submission for a spinal implant, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a 510(k) submission for a physical medical device (spinal implant), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical performance, the "ground truth" would be established by engineering principles, industry standards (e.g., ASTM standards for biomechanical testing of spinal implants), and the performance characteristics of the predicate devices. It is not clinical "ground truth" like pathology or outcomes data.
- The "truth" for substantial equivalence is based on comparing the new device's design, materials, manufacturing, indications for use, and performance to a legally marketed predicate device.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.